Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.

NCT01229072 | Suspended Phase 2

• 1 other identifier: HEPBLA0108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis. Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.

Conditions

Chronic Renal Failure

Keywords

Safety; Non-inferiority

Outcome Measures

Primary Outcomes (1)

• Safety use of the heparin in patients with renal failure.

  12 dialysis sessions

Study Arms (2)

1

EXPERIMENTAL

Heparin Blausiegel

Biological: Heparin sodic

2

ACTIVE COMPARATOR

Liquemine

Biological: heparin liquemine

Interventions

Heparin sodic BIOLOGICAL

Heparin sodic 150UI/kg

1

heparin liquemine BIOLOGICAL

Heparin sodic 150UI/kg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of both sexes, regardless of color or social class;
• Age above 18 years;
• Patients who agree to participate in the study and signed the free and informed consent (attached);
• Insufficient patients in chronic renal dialysis scheme (3 times per week);
• Low Chronic Renal indication of anticoagulant during dialysis.

You may not qualify if:

• Not agree to the terms described in informed consent;
• Patients with sensitivity to heparin sodium;
• Volunteer search with hypersensitivity to benzyl alcohol;
• Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
• Patients with a history of peptic ulcer;
• Patients with cancer of any etiology, because of the possibility of compromising the function of the variable coagulation;
• Patients in a period of pregnancy and postpartum;
• Individuals with genetic abnormality of clotting system;
• Patients polytraumatized;
• Patients in use of glucocorticoids for at least 1 month;
• Patients in use of other anticoagulants;
• Patients with high rate of bleeding;
• Patients undergo any surgery performed less than 15 days because of the risk of the formation of hematomas at the site of surgery;
• Patients in use of drugs that affect the hemostasis;
• In addition to these, clinical characteristics that the medical criteria, can interfere with the study.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 27, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (1)